Identifying Promising COVID-19 Therapies

In May 2021, the European Commission (EC) proposed a strategy on COVID-19 therapeutics for the European Union (1), which complements the already working EU Vaccines Strategy (2). This therapeutics strategy was aimed at supporting the development and availability of treatments for COVID-19, including ‘long COVID’, and just over a month after it was announced, the EC has already confirmed delivery of its first outcome (3).

So far, the commission has identified five promising candidates as COVID-19 therapeutics that are all already in advanced stages of development. “We are taking the first step towards a broad portfolio of therapeutics to treat COVID-19. Whilst vaccination is progressing at increasing speed, the virus will not disappear, and patients will need safe and effective treatments to reduce the burden of COVID-19,” said Stella Kyriakides, commissioner for Health and Food Safety in a press release (3). “Our goal is clear, we aim to identify more front-runner candidates under development and authorize at least three new therapeutics by the end of the year. This is the European Health Union in action.”

Promising candidates

The five candidates identified by the EC will be prioritized for review, and it is hoped that three of the therapies will gain authorization by October 2021, permitting the final data demonstrate safety, efficacy, and quality. Four of the products identified are monoclonal antibodies, which are already under rolling review by the European Medicines Agency (EMA), and the fifth product is an immunosuppressant that is already authorized for use but would require an extension of use to incorporate COVID-19 treatment.

Eli Lilly’s baricitinib—already approved as Olumiant as a treatment for rheumatoid arthritis and atopic dermatitis—is the immunosuppressant being considered for an extension of marketing authorization for COVID-19 indication. The monoclonal antibodies under rolling review are the combination of bamlanivimab and etesevimab (Eli Lilly), the combination of casirivimab and imdevimab (Regeneron Pharmaceuticals and F. Hoffman-La Roche), regdanvimab (Celltrion), and sotrovimab (GlaxoSmithKline and Vir Biotechnology).

A broader future

Next steps for the commission are to broaden out the pool of potential candidates to 10 therapeutics by October. These therapies will be selected with the help of an expert group on COVID-19 variants—a high-level group on the health emergency preparedness and response authority (HERA) and HERA incubator—that was formed earlier in 2021 (4).

The selection criteria for the broader portfolio of therapies will be defined by the HERA expert group and will be agreed with the EU member states. Product categories will be identified by the working group and then the most promising candidates from each category will be selected so that it will be possible to map out the continuous development of a diverse range of therapies in a dynamic fashion. It is also hoped that the broader portfolio will provide treatment options for different patient populations and different stages and severity of disease.

Depending on research and development outcomes, EMA should start further rolling reviews of other promising therapeutics by the end of 2021, the commission revealed (3). Furthermore, to ensure supply can meet demand in the cases of potential approvals, the commission is holding a virtual matchmaking event in July (5). The event will bring together stakeholders across the whole EU COVID-19 therapeutics value chain with the aim of accelerating the development and upscaling of COVID-19 therapeutics.

References

1. EC, “Coronavirus: Commission Proposes EU Strategy for the Development and Availability of Therapeutics,” ec.europa.eu, Press Release, 6 May 2021.
2. EC, “Coronavirus: Commission Unveils EU Vaccines Strategy,” ec.europa.eu, Press Release, 17 June 2020.
3. EC, “COVID-19 Therapeutics Strategy: Commission Identifies Five Promising Candidate Therapeutics,” ec.europa.eu, Press Release, 29 June 2021.
4. EC, “Register of Commission Expert Groups and Other Similar Entities: High-Level Group on the Health Emergency Preparedness and Response Authority (HERA) and HERA Incubator (E03770),” ec.europa.eu [Accessed 5 July 2021].
5. EC, “Development and Production of COVID-19 Therapeutics,” Virtual Event Notification [Accessed 5 July 2021].

About the Author

Felicity Thomas is the European editor for Pharmaceutical Technology Group.

Article Details

Pharmaceutical Technology Europe
Vol. 33, No. 7
July 2021
Page: 7

Citation

When referring to this article, please cite it as F. Thomas, “Identifying Promise” Pharmaceutical Technology Europe 33 (7) 2021.